Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490490
Recruitment Status : Terminated (Low Accrual)
First Posted : June 22, 2007
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Susan Knox, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: Bexxar (tositumomab)
Procedure: External beam radiotherapy (XRT)
Drug: Potassium Iodide (KI)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Tositumomab + XRT + KI Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Participant Flow for 2 periods

Period 1:   Completed Assessment for CR
    Tositumomab + XRT + KI

Period 2:   Completed Assessment for TTP
    Tositumomab + XRT + KI
Withdrawal by Subject                1 
Lost to Follow-up                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Tositumomab + XRT + KI Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Baseline Measures
   Tositumomab + XRT + KI 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      5  62.5% 
>=65 years      3  37.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  25.0% 
Male      6  75.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      7  87.5% 
Unknown or Not Reported      1  12.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      7  87.5% 
More than one race      0   0.0% 
Unknown or Not Reported      1  12.5% 
Histology [1] 
[Units: Participants]
Count of Participants
Follicular Lymphoma, Grade 1      2  25.0% 
Follicular Lymphoma, Grade 2      2  25.0% 
Follicular Lymphoma, Grade 3      2  25.0% 
Marginal Zone B-Cell Lymphoma      2  25.0% 

  Outcome Measures

1.  Primary:   Complete Response (CR) Rate   [ Time Frame: 12 weeks ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 12 weeks ]

3.  Secondary:   Time-to-Progression (TTP)   [ Time Frame: 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Susan J. Knox, MD, Associate Professor of Radiation Oncology
Organization: Stanford University Medical Center
phone: (650) 725-2720

Responsible Party: Susan Knox, Stanford University Identifier: NCT00490490     History of Changes
Other Study ID Numbers: IRB-07479
97437 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0046 ( Other Identifier: OnCore )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: December 19, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017